Sterilization Arrangement for Drug Delivery Device

ABSTRACT

A drug delivery system for injecting a medicament includes a housing defining a cavity, a container received within the cavity and configured to receive a medicament, the container comprising a stopper configured to move within the container and a closure, a drive assembly received within the cavity and configured to drive the stopper within the container, a needle actuator assembly received within the cavity and comprising a needle configured to be placed in fluid communication with the container, the needle moveable from a first position and a second position spaced from the first position, and a sterilizer received within the cavity and configured to sterilize at least one of the container, the drive assembly, and the needle actuator assembly upon activation of the drug delivery system.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. application Ser. No.17/153,613, filed Jan. 20, 2021, which is a continuation application ofU.S. application Ser. No. 16/160,114, filed Oct. 15, 2018, entitled“Sterilization Arrangement for Drug Delivery Device” (now U.S. Pat. No.10,926,023), which claims priority to United States ProvisionalApplication Serial No. 62/572,715, filed Oct. 16, 2017, entitled“Sterilization Arrangement for Drug Delivery Device”, the entiredisclosures of each of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates generally to a drug delivery device and,in particular, to a sterilization arrangement for a drug deliverydevice.

Description of Related Art

Various types of automatic injection or drug delivery devices have beendeveloped to allow drug solutions and other liquid therapeuticpreparations to be administered by untrained personnel or to beself-injected. Generally, these devices include a reservoir that ispre-filled with the liquid therapeutic preparation, and some type ofautomatic needle-injection mechanism that can be triggered by the user.When the volume of fluid or drug to be administered is generally below acertain volume, such as 1 mL, an auto-injector is typically used, whichtypically has an injection time of about 10 to 15 seconds. When thevolume of fluid or drug to be administered is above 1 mL, the injectiontime generally becomes longer resulting in difficulties for the patientto maintain contact between the device and the target area of thepatient's skin. Further, as the volume of drug to be administeredbecomes larger, increasing the time period for injection becomesdesirable. The traditional method for a drug to be injected slowly intoa patient is to initiate an IV and inject the drug into the patient'sbody slowly. Such a procedure is typically performed in a hospital oroutpatient setting.

Certain devices allow for self-injection in a home setting and arecapable of gradually injecting a liquid therapeutic preparation into theskin of a patient. In some cases, these devices are small enough (bothin height and in overall size) to allow them to be “worn” by a patientwhile the liquid therapeutic preparation is being infused into thepatient. These devices typically include a pump or other type ofdischarge mechanism to force the liquid therapeutic preparation to flowout of a reservoir and into the injection needle. Such devices alsotypically include a valve or flow control mechanism to cause the liquidtherapeutic preparation to begin to flow at the proper time and atriggering mechanism to initiate the injection.

SUMMARY OF THE INVENTION

In one aspect, a drug delivery system for injecting a medicamentincludes a housing defining a cavity, a container received within thecavity and configured to receive a medicament, the container comprisinga stopper configured to move within the container and a closure, a driveassembly received within the cavity and configured to drive the stopperwithin the container, a needle actuator assembly received within thecavity and comprising a needle configured to be placed in fluidcommunication with the container, the needle moveable from a firstposition and a second position spaced from the first position, and asterilization arrangement received within the cavity and configured tosterilize at least one of the container, the drive assembly, and theneedle actuator assembly upon activation of the drug delivery system.

In another aspect, the sterilization arrangement may include at leastone light source that radiates ultraviolet light to sterilize at leastone of the container, the drive assembly, and the needle actuatorassembly. The at least one light source may include at least one lightemitting diode (LED) light. The sterilization arrangement may include apower source operatively connected to the at least one light source. Thepower source may include at least one battery. The sterilizationarrangement may include a sensor operatively connected to the powersource and configured to send a signal to the power source uponinitiation of a drug delivery process for the drug delivery system. Anactuation button may be provided in the housing and movable between afirst, inactive position and a second, activation position in which adrug delivery process of the drug delivery system is initiated. Theactuation button may include a magnet that activates the sensor when theactuation button is moved from the first, inactive position to thesecond, activation position. The sensor may be a Hall Effect transistorsensor. The sterilization arrangement may include a timer operativelyconnected to the light source and configured to shut off the lightsource after a predetermined amount of time. The at least one lightsource may include four light sources. The light sources may bepositioned on different inner side surfaces of the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a drug delivery system according to oneaspect of the present invention.

FIG. 2 is a perspective, cross-sectional view of the drug deliverysystem of FIG. 1 according to one aspect of the present invention.

FIG. 3 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention.

FIG. 4 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a pre-use position.

FIG. 5 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a pre-use position.

FIG. 6 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a pre-use position.

FIG. 7 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in an initial actuationposition.

FIG. 8 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in an initial actuation position.

FIG. 9 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in an initial actuation position.

FIG. 10 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a use position.

FIG. 11 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a use position.

FIG. 12 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a use position.

FIG. 13 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a post-use position.

FIG. 14 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a post-use position.

FIG. 15 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a post-use position.

FIG. 16 is a top view of a drug delivery system including asterilization arrangement according to another aspect of the presentinvention, showing a top portion of the housing removed.

FIG. 17 is a schematic illustration of the sterilization arrangement ofthe drug delivery system of FIG. 16 .

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

Referring to FIGS. 1-15 , a drug delivery system 10 according to oneaspect of the present disclosure includes a drive assembly 12, acontainer 14, a valve assembly 16, and a needle actuator assembly 18.The drive assembly 12, the container 14, the valve assembly 16, and theneedle actuator assembly 18 are at least partially positioned within acavity defined by a housing 20. The housing 20 includes a top portion 22and a bottom portion 24, although other suitable arrangements for thehousing 20 may be utilized. In one aspect, the drug delivery system 10is an injector device configured to be worn or secured to a user and todeliver a predetermined dose of a medicament provided within thecontainer 14 via injection into the user. The system 10 may be utilizedto deliver a “bolus injection” where a medicament is delivered within aset time period. The medicament may be delivered over a time period ofup to 45 minutes, although other suitable injection amounts anddurations may be utilized. A bolus administration or delivery can becarried out with rate controlling or have no specific rate controlling.The system 10 may deliver the medicament at a fixed pressure to the userwith the rate being variable. The general operation of the system 10 isdescribed below in reference to FIGS. 1-15 .

Referring again to FIGS. 1-15 , the system 10 is configured to operatethrough the engagement of an actuation button 26 by a user, whichresults in a needle 28 of the needle assembly 18 piercing the skin of auser, the actuation of the drive assembly 12 to place the needle 28 influid communication with the container 14 and to expel fluid ormedicament from the container 14, and the withdrawal of the needle 28after injection of the medicament is complete. The general operation ofa drug delivery system is shown and described in InternationalPublication Nos. 2013/155153 and 2014/179774, which are herebyincorporated by reference in their entirety. The housing 20 of thesystem 10 includes an indicator window 30 for viewing an indicatorarrangement 32 configured to provide an indication to a user on thestatus of the system 10 and a container window 31 for viewing thecontainer 14. The indicator window 30 may be a magnifying lens forproviding a clear view of the indicator arrangement 32. The indicatorarrangement 32 moves along with the needle actuator assembly 18 duringuse of the system 10 to indicate a pre-use status, use status, andpost-use status of the system 10. The indicator arrangement 32 providesvisual indicia regarding the status, although other suitable indicia,such an auditory or tactile, may be provided as an alternative oradditional indicia.

Referring to FIGS. 4-6 , during a pre-use position of the system 10, thecontainer 14 is spaced from the drive assembly 12 and the valve assembly16 and the needle 28 is in a retracted position. During the initialactuation of the system 10, as shown in FIGS. 7-9 , the drive assembly12 engages the container 14 to move the container 14 toward the valveassembly 16, which is configured to pierce a closure 36 of the container14 and place the medicament within the container 14 in fluidcommunication with the needle 28 via a tube (not shown) or othersuitable arrangement. The drive assembly 12 is configured to engage astopper 34 of the container 14, which will initially move the entirecontainer 14 into engagement with the valve assembly 16 due to theincompressibility of the fluid or medicament within the container 14.The initial actuation of the system 10 is caused by engagement of theactuation button 26 by a user, which releases the needle actuatorassembly 18 and the drive assembly 12 as discussed below in more detail.During the initial actuation, the needle 28 is still in the retractedposition and about to move to the extended position to inject the userof the system 10.

During the use position of the system 10, as shown in FIGS. 10-12 , theneedle 28 is in the extended position at least partially outside of thehousing 20 with the drive assembly 12 moving the stopper 34 within thecontainer 14 to deliver the medicament from the container 14, throughthe needle 28, and to the user. In the use position, the valve assembly16 has already pierced a closure 36 of the container 14 to place thecontainer 14 in fluid communication with the needle 28, which alsoallows the drive assembly 12 to move the stopper 34 relative to thecontainer 14 since fluid is able to be dispensed from the container 14.At the post-use position of the system 10, shown in FIGS. 13-15 , theneedle 28 is in the retracted position and engaged with a pad to sealthe needle 28 and prevent any residual flow of fluid or medicament fromthe container 14. The container 14 and valve assembly 16 may be thecontainer 14 and valve assembly 16 shown and described in InternationalPublication No. WO 2015/081337, which is hereby incorporated byreference in its entirety.

Referring to FIGS. 16 and 17 , in one aspect, a sterilizer is alsoprovided in the system 10. The sterilizer includes a light source 50 tosterilize the inner components of the system 10. In one aspect, thelight source 50 provides ultraviolet (UV) light to the inner cavity ofthe housing 20. The UV light provided by the light source 50 is directedto the inner components of the system 10 to sterilize the innercomponents, such as the drive assembly 12, the container 14, the valveassembly 16, and the needle actuator assembly 18. In one aspect, thelight source 50 includes one or more light emitting diode (LED) lights.In one aspect, a single light source 50 is provided in the housing 20.It is also contemplated that a plurality of light sources 50 areprovided in the housing 20. In one aspect, four light sources 50 areprovided in the housing 20. In one aspect, the light source 50 shines UVlight on each component in the system 10. In another aspect, the lightsource 50 shines UV light on a portion of the components in the system10. Any bacteria or contaminants growing or developing inside of thesystem 10 are sterilized by the UV light to provide a sterileenvironment inside the housing 20. In one aspect, the light sources 50are each positioned on a different inner side surface of the housing 20.

Referring again to FIGS. 16 and 17 , in one aspect, the light sources 50are connected to a power source 52. The power source 52 may be anyarrangement capable of providing power to illuminate the light sources50. The power source 52 may be provided within the housing 20. Inparticular, the power source 52 may be provided on the top portion 22and/or the bottom portion 24. In one aspect, the power source 52includes at least one battery. It is also contemplated that the powersource 52 may be provided as a power source external to the housing 20.For example, the power source 52 may be a battery pack wired to thehousing 20, but provided external to the housing 20. The power source 52may be replaceable and/or rechargeable. In one aspect, a plurality ofbatteries are provided as the power source 52 to power the light sources50. The batteries may be charged by an external connector, such as acord extending to an electrical outlet, or by an induction arrangement(not shown).

Referring again to FIGS. 16 and 17 , a sensor 54 is also provided in thehousing 20 to actuate the light sources 50 upon initiation of the drugdelivery actuation process. The sensor 54 is configured to sense whenthe drug delivery actuation process has been initiated and sends asignal to the power source 52 to supply power from the power source 52to the light sources 50 so that UV light is emitted by the light sources50 to sterilize one or more components in the system 10. In one aspect,the sensor 54 is a Hall Effect transistor sensor that cooperates with amagnet 56 provided on or in a switch or button of the system 10. In oneaspect, the sensor 54 is provided on the actuation button 26 of thesystem 10. It is also contemplated that the sensor 54 could be providedon a switch or button (not shown) separate from the actuation button 26so that the light source 50 could be activated independently of the drugdelivery actuation process. When the actuation button 26 of the system10 is actuated, the sensor 54 sends a signal to activate the powersource 52 to supply power to the light sources 50. Therefore, as thesystem 10 proceeds through the drug delivery process, the light sources50 sterilize the inner components of the system 10. In another aspect, atimer 58 is connected to the power source 52 so that, after apredetermined amount of time of activation, the light sources 50 will beturned off. The length of time that the light sources 50 are activatedis adjustable by the timer 58.

Referring to the device of FIG. 16 and the logic diagram of FIG. 17 , amethod of sterilizing a drug delivery system 10 is described. Asdescribed above, to actuate the drug delivery process, the actuationbutton 26 is depressed. As the actuation button 26 is depressed, themagnet 56 provided in the actuation button 26 actuates the sensor 54.The sensor 54 sends a signal to the power source 52 to activate thepower source 52. The power source 52 then supplies power to the lightsources 50 to activate the LED lights within the light sources 50. TheLED lights of the light sources 50 cast UV light over the innercomponents of the system 10 to sterilize the inner components. In oneaspect, the UV light is cast on at least one of the drive assembly 12,the container 14, the valve assembly 16, and the needle actuatorassembly 18. It is also contemplated that the UV light may be cast oneach of the drive assembly 12, the container 14, the valve assembly 16,and the needle actuator assembly 18. With the actuation button 26 havingbeen depressed and the light sources 50 having been activated, after apredetermined amount of time, the timer 58 shuts off the light sources50 to stop the emittance of the UV light. After use of the system 10, auser can recharge the power source 54 either internally or externally ofthe housing 20.

Elements of one disclosed aspect can be combined with elements of one ormore other disclosed aspects to form different combinations, all ofwhich are considered to be within the scope of the present invention.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A wearable drug delivery system comprising: ahousing defining a cavity, the housing comprising a window configured toallow a patient to view a portion of the cavity; a medicament containerconfigured to be received within the cavity and to receive a medicament;a first needle configured to be placed in fluid communication with themedicament container, the first needle having a first position spacedfrom the medicament container, and a second position in which at least aportion of the first needle is received within the medicament container;and a second needle configured to pierce a patient's skin, and todeliver the medicament to the patient, the second needle in fluidcommunication with the first needle; an adhesive coupled to the housingand configured to releasably couple the wearable drug delivery system tothe patient's skin; a button to initiate a drug delivery process; anultraviolet (UV) light source received within the cavity and configuredto sterilize a portion of inner surfaces of the wearable drug deliverysystem following initiation of the drug delivery process; a power sourceoperatively connected to the UV light source; a timer operativelyconnected to the UV light source and configured to shut off the UV lightsource after a predetermined amount of time; and an indicator configuredto convey a status of the drug delivery process.
 2. The wearable drugdelivery system of claim 1, wherein the window is configured to allow apatient to view a portion of the medicament container.
 3. The wearabledrug delivery system of claim 1, wherein the UV light source comprises alight emitting diode (LED) that is configured to emit UV light tosterilize a portion of the inner surfaces of the wearable drug deliverysystem.
 4. The wearable drug delivery system of claim 3, wherein the LEDsterilizes a portion of the container.
 5. The wearable drug deliverysystem of claim 3, wherein the LED sterilizes a portion of the firstneedle.
 6. The wearable drug delivery system of claim 3, wherein the UVlight source comprises a plurality of LEDs.
 7. The wearable drugdelivery system of claim 3, further comprising a sensor configured todetect when the button has initiated the drug delivery process and tocause the power source to supply power to the LED.
 8. The wearable drugdelivery system of claim 1, wherein the indicator comprises an auditory,a tactile, or a visual indicator.
 9. The wearable drug delivery systemof claim 8, wherein the indicator is a visual indicator.
 10. Thewearable drug delivery system of claim 9, wherein the visual indicatoris arranged within the housing and is visible through the window. 11.The wearable drug delivery system of claim 8, wherein the indicator isconfigured to indicate a pre-use status, a use status, and a post-usestatus.
 12. The wearable drug delivery system of claim 1, wherein thesecond needle is moveable between an extended position and a retractedposition.
 13. The wearable drug delivery system of claim 1, wherein theadhesive is an adhesive pad.
 14. The wearable drug delivery system ofclaim 1, further comprising a drive assembly received within the cavityand configured to cause medicament to be expelled from the contained.15. The wearable drug delivery system of claim 14, wherein the driveassembly is configured to deliver medicament to the patient at a fixedpressure.
 16. The wearable drug delivery system of claim 14, wherein thedrive assembly is configured to deliver medicament to the patient at afixed rate.
 17. The wearable drug delivery system of claim 14, whereinthe UV light source comprises a LED that is configured to emit UV lightto sterilize a portion of the drive assembly.